2023
A randomized phase III study of standard versus high-dose cytarabine with or without vorinostat for AML
Garcia-Manero G, Podoltsev N, Othus M, Pagel J, Radich J, Fang M, Rizzieri D, Marcucci G, Strickland S, Litzow M, Savoie M, Medeiros B, Sekeres M, Lin T, Uy G, Powell B, Kolitz J, Larson R, Stone R, Claxton D, Essell J, Luger S, Mohan S, Moseley A, Appelbaum F, Erba H. A randomized phase III study of standard versus high-dose cytarabine with or without vorinostat for AML. Leukemia 2023, 38: 58-66. PMID: 37935977, DOI: 10.1038/s41375-023-02073-x.Peer-Reviewed Original ResearchConceptsHigh-dose cytarabineAcute myeloid leukemiaDose cytarabineRandomized phase III studyUnfavorable-risk cytogeneticsRandomized multicenter trialOverall remission ratePhase III studyHigh response rateHistone deacetylase inhibitorsInduction therapyFree survivalPrimary endpointRemission rateUntreated patientsIII studyOverall survivalYounger patientsMulticenter trialImproved outcomesMyeloid leukemiaCytogenetic subsetsCytarabineResponse rateHigh doses
2013
First Clinical Results Of a Randomized Phase 2 Study Of SGI-110, a Novel Subcutaneous (SQ) Hypomethylating Agent (HMA), In Adult Patients With Acute Myeloid Leukemia (AML)
Kantarjian H, Jabbour E, Yee K, Kropf P, O'Connell C, Stock W, Tibes R, Rizzieri D, Walsh K, Griffiths E, Roboz G, Savona M, Ervin T, Podoltsev N, Pemmaraju N, Daver N, Garcia-Manero G, Borthakur G, Wierda W, Ravandi F, Cortes J, Brandwein J, Odenike O, Feldman E, Chung W, Naim S, Choy G, Taverna P, Hao Y, Dimitrov G, Azab M, Issa J. First Clinical Results Of a Randomized Phase 2 Study Of SGI-110, a Novel Subcutaneous (SQ) Hypomethylating Agent (HMA), In Adult Patients With Acute Myeloid Leukemia (AML). Blood 2013, 122: 497. DOI: 10.1182/blood.v122.21.497.497.Peer-Reviewed Original ResearchAcute myeloid leukemiaPhase 2 studyTreatment of AMLRandomized phase 2 studyRefractory acute myeloid leukemiaOverall remission rateAdverse eventsComplete remissionRemission rateAstex PharmaceuticalsHypomethylating agentAML patientsSGI-110Primary endpointDose groupElderly acute myeloid leukemiaLINE-1 demethylationElderly AML patientsCommon adverse eventsComplete remission ratePhase 1 trialStem cell transplantPhase 3 investigationFirst clinical resultsECOG PS